Info Service on WTO and Trade Issues (Mar14/02)
18 March 2014
Third World Network
encouraged to use TRIPS flexibilities for public health
Published in SUNS #7758 dated 7 March 2014
Geneva, 6 Mar (Kanaga Raja) -- The Geneva-based South Centre has encouraged
India and other developing countries "to continue to make full
use of the TRIPS flexibilities for public health and other public
policy objectives," consistent with their rights and obligations
under the World Trade Organisation (WTO) rules.
In a statement released here, the intergovernmental organisation of
developing countries called on WTO Members to respect the legitimacy
of the use of TRIPS flexibilities for public health in light of new
threats of unilateral trade measures by the United States against
India over its intellectual property (IP) laws and regulations.
The South Centre statement cautioned that continued pressures by the
United States on India and other developing countries "to adopt
an IPRs [Intellectual Property Rights] regime that would go beyond
the minimum standards in the TRIPS [Trade-Related Aspects of Intellectual
Property Rights] Agreement and that does not make use of the flexibilities
that are part of TRIPS would have adverse social and developmental
effects, including on the public's access to medicines."
"The US administration should also stop putting pressures on
developing countries to prevent them from making use of their rights
under the TRIPS Agreement to make use of policy measures to promote
access to medicines, public health and other development objectives,"
the South Centre emphasised.
In its statement, the South Centre expressed deep concern that developing
countries, and more recently, the government of India, are facing
increasing pressure from the United States to reform their intellectual
property (IP) laws.
The South Centre asserted that the Indian IP laws include balanced
provisions to ensure that IP rights do not hinder the ability of the
government to adopt measures for promoting development priorities,
particularly in the area of public health.
"These are fully in line with the TRIPS Agreement and reaffirmed
by the Doha Declaration on TRIPS and Public Health," it stressed.
According to the South Centre statement, the United States International
Trade Commission (USITC) has initiated investigations against India
on its trade, investment and industrial policies, particularly on
intellectual property protection and enforcement.
[The USITC had held public hearings last month as part of its investigation
titled "Trade, Investment and Industrial Policies in India: Effects
on the US Economy". The investigation was initiated at the instance
of both the Senate Committee on Finance and the House Committee on
Ways and Means, with support from several US industry associations
including the Pharmaceutical Research and Manufacturers of America
[A number of civil society groups also testified against the positions
of PhRMA and industry associations, and supported India's use of compulsory
licensing, as well as pointing to the US itself issuing such licenses.
See SUNS #7743 dated 14 February 2014.]
In its statement, the South Centre also said that the United States
Trade Representative (USTR) is being asked to include India as a priority
foreign country in the Special 301 review for 2014, at the request
of US industry associations including PhRMA, the Biotechnology Industry
Organization (BIO), the National Manufacturers Association (NAM),
the National Foreign Trade Council (NFTC), the US Chamber of Commerce's
Global Intellectual Property Centre, and the Alliance for Fair Trade
with India (AFTI), alleging lack of adequate and effective protection
of intellectual property rights (IPRs).
"The South Centre views these recent developments as most inappropriate,
as it is against the spirit of the landmark Ministerial Declaration
on TRIPS Agreement and Public Health."
It underlined that India and other developing and least developed
countries (LDCs) have the right to use the flexibilities in the TRIPS
Agreement to the fullest extent for advancing public health needs
and other development priorities.
Pointing out that the legal and regulatory measures that India has
used for protecting public health are fully consistent with the WTO
TRIPS Agreement, the South Centre said that the "continued threat
of unilateral trade sanctions by the US to developing countries through
USITC investigations and the Special 301 review undermines the legitimacy
of the WTO, particularly the TRIPS Agreement and the WTO's dispute
It is regrettable that India or any other developing country may be
designated as a "priority foreign country" under the "Special
301" provisions of the US Trade Act of 1974, the South Centre
Designation as a "priority foreign country" starts a 30-day
period during which targeted countries must engage in good faith negotiations
or make significant progress in bilateral or multilateral negotiations
or face sanctions under the section 301 process.
The South Centre statement explained that priority foreign country
determinations are reserved for countries "that have the most
onerous or egregious acts, policies, or practices," that "have
the greatest adverse impact (actual or potential) on the relevant
US products," and for which "there is a factual basis for
the denial of fair and equitable market access as a result."
"The USTR investigation may lead to unilateral trade sanctions
that would be illegitimate under the WTO rules," it said. "The
mere threat of sanctions by placing a country in any specific category
in the US watch list would appear to violate the WTO Dispute Settlement
A WTO panel noted, in a dispute brought in 1999 by the EU against
Section 301 of the US law, that "the threat alone of conduct
prohibited by the WTO would enable the Member concerned to exert undue
leverage on other Members. It would disrupt the very stability and
equilibrium which multilateral dispute resolution was meant to foster
and consequently establish, namely equal protection of large and small,
powerful and less powerful Members through the consistent application
of a set of rules and procedures."
The South Centre statement also noted that separately, at the request
of the US Senate Committee on Finance and the House Committee on Ways
and Means with backing from various US industry associations including
PhRMA, the USITC has launched an investigation (on India's trade,
investment and industrial policies).
The South Centre underlined that the establishment by the government
of a country of its criteria to grant patents (as provided for in
section 3(d) of the Indian Patent Act and interpreted by the Indian
Supreme Court in the Novartis case), the right to issue compulsory
licenses, and the use of patent pre-grant and post-grant opposition
proceedings are, among others, "important flexibilities that
serve to protect public health, consistent with the TRIPS Agreement."
"None of the recent decisions in India to reject patents on known
medicines or to issue compulsory licenses on anti-cancer medicines
have been challenged before the WTO dispute settlement mechanism,"
In fact, the statement pointed out, the recent actions taken by India
are not unique. Many other developing countries have issued compulsory
licenses for ensuring access to affordable medicines to meet their
public health needs, including Brazil, Ecuador, Eritrea, Ghana, Indonesia,
Malaysia, Mozambique, Thailand and Zambia.
"The TRIPS Agreement also does not preclude that countries include
in their patent laws a requirement to disclose the source and geographical
origin of biological materials used in an invention that is the subject
of a patent application," said the South Centre.
The disclosure requirement is conducive to the mutually supportive
implementation of the TRIPS Agreement and the Convention on Biological
Diversity and the Nagoya Protocol on Access and Benefit-Sharing, it